Clinical Efficacy Of Intra-articular Mesenchymal Stem Cells For The Treatment Of Knee Osteoarthritis: A Double Blinded, Prospective, Randomized, Controlled Clinical Trial
Notice bibliographique
Résumé
Objectives: Currently, there are limited non-operative treatment options available for knee osteoarthritis (OA). Stem cell based therapies have emerged as promising non-operative treatments for knee OA. Various stem cell mediums have been investigated, but there are limited prospective, randomized controlled trials for any of these therapies. This study aimed to investigate the 6 month and 1 year efficacy of intra-articular injections of autologous stromal vascular fraction stem cell therapy (SVF) in a double blinded, prospective, randomized, placebo controlled trial. Methods: This was a multi-site prospective, randomized, double-blinded clinical trial. Adult patients with symptomatic knee OA were eligible for enrollment. Patients were randomized to high dose SVF injection (3.0×107 SVF cells), low dose SVF injection (1.5×107 SVF cells), or placebo injection (zero SVF cells) in a 1:1:1 fashion. SVF was obtained via liposuction, which was then processed and injected during the same clinic visit. Knee function was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. MRIs were reviewed for changes in the cartilage thickness of chondral lesions. WOMAC scores and MRIs were obtained before injection, and at 6 and 12 months post-injection. The Wilcoxon Rank Sum non-parametric test was utilized to assess statistical significance and the Hodges-Lehmann Location Shift (HLLS) with confidence intervals was used to assess superiority. Results: A total of 39 participants were enrolled (high dose: 13, low dose: 13, placebo: 13). The median percent change in WOMAC scores from pre-injection to 6 months post-injection for the high dose group, low dose group, and placebo group were 83.9%, 51.5% and 25.0%, respectively. The high dose and low dose groups displayed a significantly greater percent change in WOMAC scores compared to the placebo group (high dose: p=0.04; low dose: p=0.02).The median percent change in WOMAC scores from baseline to 1 year post-injection for the high dose group, low dose group, and placebo group were 89.5%, 68.2%, and 0%, respectively. Similar to the 6 month evaluation, the high dose and low dose groups displayed a greater percent change in 1 year WOMAC scores compared to the placebo group (high dose: p = 0.006, low dose: p = 0.009). The 6-month follow-up MRIs demonstrated no change in cartilage thickness for all subjects. The mean change in cartilage thickness for the treatment group (high dose and low dose) and the placebo group was -0.2mm and 0.5 mm, respectively, with no statistical difference between groups (p= 0·89). During the 12 months post-injection there were no serious adverse events, or evidence of neoplastic growths. Conclusion: Intra-articular injection of both high dose and low dose SVF cells provides significant improvement in knee OA symptoms for at least 1 year post-injection. Knee function in all patients improved during the first 6 months post-injection; however, both high and low dose treatment groups experienced significantly greater improvement than the placebo group. The symptomatic treatment effect was found to be dose dependent. Furthermore, while WOMAC scores continued to improve for both treatment groups during the 6 months to 1 year period, the placebo group returned to baseline during the same time interval. The efficacy of SVF injections, in combination with its safety and ease of use, support its’ use as a treatment option for symptomatic knee osteoarthritis.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,009 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,003 | 0,001 |
| Méta-épidémiologie (sens large) | 0,008 | 0,003 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,003 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,005 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».